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Remote endarterectomy is a minimally invasive procedure which combines open and endovascular surgery for the treatment of long segment superficial femoral artery (SFA) occlusive disease. We conducted a systematic review of the medical literature to analyze the indications, technical limitations and the outcome of remote SFA endarterectomy (RSFAE).
Methods
The English literature was searched using the MEDLINE electronic database up to February 2008. We considered studies comprising at least 10 patients treated with RSFAE and reporting on the primary and/or secondary patency rates. Average primary and secondary patency rates were obtained by weighting the data of each study by the number of limbs treated.
Results
Our search identified 19 retrospective or prospective case series; no randomized controlled trials comparing RSFAE with another treatment modality were identified. The average technical success rate was 94% and the procedure-related complication rate was 14.7%. The weighted mean cumulative primary patency rates were 60%, 57% and 35% at 1, 2 and 5 years, respectively. The weighted mean assisted primary patency rates were 75%, 77% and 50% at 1, 2 and 5 years, respectively. The weighted mean secondary patency rates were 88% and 62% at 1 and 2 years, respectively.
Conclusions
RSFAE has acceptable short-, medium- and long-term results but patients should undergo intensive surveillance postoperatively. Randomized controlled trials are needed to assess the durability of this procedure as compared to conventional open bypass surgery.
Historically, femoro-popliteal bypass has been considered the gold standard for the treatment of long segmental SFA occlusive disease and the ideal graft is autologous saphenous vein, whereas percutaneous transluminal angioplasty and/or stenting has been suggested by the Transantlantic Inter-Society Consensus (TASC) for the treatment of short TASC type A lesions.
in the middle of the previous century. Instead of the direct open approach for arterial endarterectomy, the author proposed a semi-closed approach using a proximal and distal arteriotomy and a ring stripper for the removal of the atheroma from the femoro-popliteal segment. Despite the initial enthusiasm and the theoretical advantages of the procedure, its use gradually reduced, as large trials showed inferior results compared with vein bypass grafting.
In the modern era of endovascular approaches, Ho et al.
The Mollring Cutter remote endarterectomy: preliminary experience with a new endovascular technique for treatment of occlusive superficial femoral artery disease.
instigated new interest in SFA endarterectomy with the evolution of the “remote” technique. This is a minimally invasive procedure for the treatment of long segment SFA occlusion, which combines open and endovascular surgery (Fig. 1).
Through a single groin incision and an arteriotomy in the proximal SFA, the atherosclerotic core is dissected out of the arterial adventitia using a ring stripper and a ring strip cutter is then used to transect the distal intimal core. Endoluminal stenting of the distal intimal flap prevents any further dissection and provides a smooth transition area.
Figure 1(a) The atherosclerotic core is dissected out of the arterial wall with a ring stripper. (b) The ring strip cutter transects the distal intimal core (arrow). (c) The whole intimal-atherosclerotic column has been removed. (d) A stent has been placed to cover the distal intimal flap (arrow).
The purpose of this article was to systematically review the literature and analyze the indications, technical details and the outcome of RSFAE based on evidence derived from relevant studies.
Methods
Search strategy. A public domain database (MEDLINE) was searched using a Web-based search engine (PubMed) for articles published between August 1995, when the technique of remote endarterectomy was first described, and February 2008. The literature search was confined to studies published in English. The keywords used were “remote endarterectomy” and “superficial femoral artery AND endarterectomy”. A second-level search included manual search of the reference lists of relevant articles. The literature search, study selection, and data extraction from the relevant studies were performed by two independent authors (GAA, SAA).
Study selection. Studies were considered for inclusion based on the following criteria: 1. They included at least 10 patients with SFA occlusive disease treated with RSFAE, 2. They reported the primary and/or secondary patency rates. The process of identifying eligible clinical studies is summarized in Fig. 2. Our search initially located 195 abstracts, and a full-text online library tool was used to retrieve 28 relevant articles. Nineteen of these articles fulfilled the above inclusion criteria.
Data abstraction and statistical analysis. Data abstracted (where available) from individual studies were: type of study (single or multi-centre, retrospective or prospective), number of patients/legs treated, demographic characteristics of the study population, Rutherford classification for lower extremity ischaemia, nature of SFA lesion, number of run-off vessels, technical success rate, reasons for technical failure, procedure-related complications, type of stent used, SFA endovascular grafting, mean in-hospital stay, postoperative anticoagulation, mean ABPI increase, patency rates, number of secondary interventions to maintain patency, secondary bypass surgery rate and amputation rate. The mean technical success rate and mean cumulative primary, assisted primary and secondary patency rates were averaged, weighting the data of each study by the number of limbs treated. These patency values were calculated for 12, 24 and 60 months following the procedure. Values were presented for a specific time-period only if there were at least two studies to report for this time-period.
Results
Nineteen relevant studies were identified using the aforementioned criteria.
Multi centre study to assess the feasibility of a new covered stent and delivery system in combination with remote superficial femoral artery endarterectomy (RSFAE).
Endovascular remote endarterectomy in femoropopliteal long segmental occlusive disease. A new surgical technique illustrated and preliminary results using a ring strip cutter device.
Endovascular remote endarterectomy in femoropopliteal long segmental occlusive disease. A new surgical technique illustrated and preliminary results using a ring strip cutter device.
which included 14 clinical studies (Fig. 2). All of these studies were retrospective or prospective case series, single- or multicentre, as shown in Table 1. No randomized controlled trials were found comparing RSFAE with another treatment modality for SFA occlusive disease. Four multi-centre studies have been conducted,
Multi centre study to assess the feasibility of a new covered stent and delivery system in combination with remote superficial femoral artery endarterectomy (RSFAE).
Multi centre study to assess the feasibility of a new covered stent and delivery system in combination with remote superficial femoral artery endarterectomy (RSFAE).
The total number of patients and legs selected for RSFAE is 952 and 1001, respectively. The patients' demographic characteristics are shown in Table 2 and the clinical and anatomical inclusion criteria for RSFAE are presented in Table 3. It is evident from this table that there is wide variability in the Rutherford caregory. In particular, Rosenthal et al.
included patients treated for limb salvage only and RSFAE was combined with distal vein bypass. There is also considerable heterogeneity in the anatomical inclusion criteria for RSFAE. In some studies the nature of the lesion (occlusion/stenosis) as well as the length of occlusion is clearly stated, whereas in some others the anatomical criteria are ill-defined or not defined at all (Table 3). Similarly, some studies comment on the status of the run off vessels while others do not (Table 3). Almost all studies though converge on the fact that the anatomical criteria for RSFAE are multiple stenoses or lengthy occlusion of the SFA with supragenicular reconstitution of the popliteal artery and at least one patent crural vessel.
Multi centre study to assess the feasibility of a new covered stent and delivery system in combination with remote superficial femoral artery endarterectomy (RSFAE).
Multi centre study to assess the feasibility of a new covered stent and delivery system in combination with remote superficial femoral artery endarterectomy (RSFAE).
RC, Rutherford classification; v, run off vessel; p, patient; v:p, number of patients having the specific number of patent run off vessels; NR, not reported.
The technical success rate for each individual study is shown in Table 4. The technical success rate ranges from 65 to 100% and the mean technical success rate was 94%. All patients with failed RSFAE underwent successful femoro-popliteal bypass. Table 5 summarizes the reasons for technical failure sorted by frequency. The most common reason for procedural failure is SFA perforation, encountered in 2.1% of the reported RSFAE attempts, followed by SFA calcification (1.3%) and failure to pass the guide wire across the popliteal plaque end-point (0.5%).
Multi centre study to assess the feasibility of a new covered stent and delivery system in combination with remote superficial femoral artery endarterectomy (RSFAE).
Additionally, Table 5 summarizes the procedure-related complications sorted by frequency. The procedure-related complication rate was 14.7%. The most common procedure-related complication was thrombus or fractured plaque within the SFA, which was usually successfully removed with an embolectomy catheter. There was also a 5.4% risk of SFA perforation or rupture, demonstrated as extravasation of contrast at completion arteriography, which in the majority of cases was self-limiting requiring no intervention, whereas in a few cases graft or stent placement was required. Popliteal access was required in 1.2% of successful RSFAEs, most commonly in cases in which there was difficulty in crossing the guide wire from the distal endarterectomy end-point.
Table 6 presents the type of stent and/or endograft used for fixation of the distal endarterectomy end-point and prevention of restenosis.
Multi centre study to assess the feasibility of a new covered stent and delivery system in combination with remote superficial femoral artery endarterectomy (RSFAE).
Use of postoperative antithrombotic or anticoagulation therapy varied considerably between the studies, while some studies did not report on this treatment at all (Table 7).
Multi centre study to assess the feasibility of a new covered stent and delivery system in combination with remote superficial femoral artery endarterectomy (RSFAE).
The immediate outcome was demonstrated by the mean ABPI increase (Table 8), which ranged from 0.26 to 0.52. Postoperatively, all patients underwent a surveillance program which included clinical examination, ABPI measurement and duplex scanning carried out at 3-monthly intervals. The short, medium and long term results of various studies are represented by the patency rates (Table 8). The weighted mean cumulative primary patency rates at 1, 2 and 5 years were 60%, 57% and 35%, respectively. The weighted mean assisted primary patency rates were 75%, 77% and 50% at 1, 2 and 5 years, respectively. The weighted mean secondary patency rates were 88% and 62% at 1 and 2 years, respectively (Table 9). Only two studies
reported on the long term (60 months) results of RSFAE reporting mean weighted cumulative and assisted primary patency rates of 35% and 50%, respectively.
Multi centre study to assess the feasibility of a new covered stent and delivery system in combination with remote superficial femoral artery endarterectomy (RSFAE).
Multi centre study to assess the feasibility of a new covered stent and delivery system in combination with remote superficial femoral artery endarterectomy (RSFAE).
Multi centre study to assess the feasibility of a new covered stent and delivery system in combination with remote superficial femoral artery endarterectomy (RSFAE).
Multi centre study to assess the feasibility of a new covered stent and delivery system in combination with remote superficial femoral artery endarterectomy (RSFAE).
A number of interventions were performed to maintain patency, including percutaneous transluminal balloon and stent angioplasty, thrombectomy, thrombolysis and surgical revision of the proximal and distal SFA, with a rate which ranged from 9.1 to 63.4% (Table 10, Fig. 3). The indications for intervention to maintain patency varied among the studies depending on recurrent clinical symptoms and haemodynamic and duplex scanning parameters.
Table 10Rate of secondary interventions, bypass rate and amputation rate
Multi centre study to assess the feasibility of a new covered stent and delivery system in combination with remote superficial femoral artery endarterectomy (RSFAE).
Figure 3(a) Haemodynamically significant stenosis developed four months later at the distal end of the endarterectomized SFA, where a stent had been deployed. (b) Correction of the lesion with cutting balloon angioplasty and placement of a covered stent (VIABAHN).
The percentage of patients who eventually required femoro-popliteal bypass after failure of RSFAE ranged from 4.8 to 36.4% and the amputation rate varied from 0 to 28.6% (Table 10).
Discussion
Although RSFAE appears to be an appealing concept for the treatment of long SFA lesions, this method has not yet been validated as a treatment option. There are no randomized controlled trials comparing RSFAE with another treatment modality for SFA occlusive disease, such as subintimal angioplasty or femoropopliteal bypass. Our review of the literature on this occasion was focused in the assessment of the feasibility and outcomes of remote endarterectomy. The search of the pertinent literature has detected retrospective or prospective case series only, among which there was great variability in several aspects, including demographic characteristics of the study population, clinical and angiographic inclusion criteria for this treatment, and the reporting of outcomes. Pooled analysis of the existing literature was not possible because of these limitations. Therefore, the outcomes of RSFAE presented herein should be approached with caution.
Our analysis of the relevant articles has shown that the procedure was associated with a 6% failure rate and a procedural complication rate of 14.7%. The most common reasons for technical failure were SFA calcification and SFA perforation accounting for 78% of the technical failures. This percentage might be even higher if Martin et al.
had not largely excluded patients with extensive SFA calcification or renal failure from their studies. It is therefore rational to argue that patients with heavy calcification of the SFA should probably not be considered for RSFAE. Failure to pass the guide wire across the distal plaque end-point might have accounted for a higher percentage of the total technical failures if Devalia et al.
had not modified the original technique by passing the guide wire into the popliteal artery, distal to the occlusion, under local anaesthesic prior to the operative procedure.
In the existing literature most procedure-related complications were minor requiring no major intervention or conversion to conventional open bypass surgery.
included positioning of a short balloon-expandable Palmaz stent over the distal intimal edge to prevent any further dissection. A few years later the same authors
proposed placement of an endograft to cover the whole length of the endarterectomised SFA combined with distal stent placement. The technique was based on the observation
Incidence, time-of-onset, and anatomical distribution of recurrent stenoses after remote endarterectomy in superficial femoral artery occlusive disease.
that 46% of the limbs treated with RSFAE developed recurrent stenoses located within the endarterectomised SFA segment after a mean interval of 5.8 months. Recently three multi-centre studies used a new stent made of nickel titanium, manufactured in a double spiral configuration and covered with ePTFE, which has the advantages of high radial strength, flexibility and resistance to compression and torsional stresses proximal to the knee joint.
Multi centre study to assess the feasibility of a new covered stent and delivery system in combination with remote superficial femoral artery endarterectomy (RSFAE).
No evidence exists to justify the superiority of this stent over the other stents used. Additionally, no randomized trials have been found comparing the efficacy of stent or endograft placement.
All studies assessed demonstrated considerable immediate clinical improvement after RSFAE represented by the mean ABPI increase. The weighted mean cumulative primary and assisted primary patency rates were 57 and 77% at 2 years, respectively. Five year results after RSFAE were reported by two studies only.
in which 183 limbs were treated, reported a secondary patency rate of 49% at 5 years. From the existing literature, it appears that the outcomes of RSFAE are not significantly inferior to those of subintimal angioplasty or femoropopliteal by-pass.
However, to draw definite conclusions at least one randomized study comparing the outcome of RSFAE with that of subintimal angioplasty and femoro-popliteal bypass is required.
The large number of interventions required to maintain assisted and secondary patency following RSFAE suggests that patients should undergo an intensive clinical and duplex surveillance program postoperatively to detect restenosis and/or reocclusion, which probably needs to be continued indefinitely.
found that, excluding the cost of duplex surveillance, the cost of maintaining RSFAE patency was approximately five times that of maintaining in situ bypass patency. It was concluded that the initial cost advantage of shortened hospital stay is probably offset by the increased cost of maintaining patency. Of interest is the observation by various authors that reocclusion of the SFA due to failed RSFAE was not associated with worsening of symptoms compared with the preoperative state, which might be explained by the reopening and preservation of SFA collaterals. Smeets et al.
found that 80% of patients who had undergone RSFAE had improved or unchanged symptoms following re-occlusion, reporting an amputation rate of 0.8%.
In conclusion, long segment SFA disease has been traditionally difficult to treat with endovascular techniques. RSFAE is a relatively new minimally invasive technique whose role in the treatment of peripheral arterial disease remains to be defined. Our review has shown that RSFAE carries acceptable technical success rates and complication rates, and short-, medium- and long-term results. RSFAE does require a large number of secondary interventions to maintain patency. Patients should undergo at least 1-year postoperative clinical and duplex scanning surveillance. At present it is unclear whether this treatment compares favorably with conventional bypass surgery or with other treatment modalities for long segment SFA disease, such as subintimal angioplasty, as there are no randomized controlled trials comparing RSFAE with other treatments. Thus further research is needed to assess the usefulness of RSFAE.
References
Klinkert P.
Schepers A.
Burger D.H.
van Bockel J.H.
Breslau P.J.
Vein versus polytetrafluoroethylene in above-knee femoropopliteal bypass grafting: five-year results of a randomized controlled trial.
The Mollring Cutter remote endarterectomy: preliminary experience with a new endovascular technique for treatment of occlusive superficial femoral artery disease.
Multi centre study to assess the feasibility of a new covered stent and delivery system in combination with remote superficial femoral artery endarterectomy (RSFAE).
Endovascular remote endarterectomy in femoropopliteal long segmental occlusive disease. A new surgical technique illustrated and preliminary results using a ring strip cutter device.
Incidence, time-of-onset, and anatomical distribution of recurrent stenoses after remote endarterectomy in superficial femoral artery occlusive disease.
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